Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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The Case Of The Half Pill: AI As Outsourcing Detective

A number of patients report receiving half a pill in a blister pack of their prescribed medicine. The initial sponsor reaction is to place the problem at an external partner’s production or packaging line. But overall responsibility lies with the sponsor, and the true extent of the problem is hard to detect. Enter AI. Experienced pharma quality expert Damiano Dragone believes AI combined with professionals throughout the supply chain can join in a new “logic and creativity" to improve our industry on behalf of patients.

GUEST COLUMNISTS

Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
US Pharma Reshoring: The Full Policy Timeline
As policy shifts and manufacturing investments reshape pharma supply chains, capacity constraints and global dependencies persist. Explore the implications for long-term resilience.

PHARMA OUTSOURCING WHITE PAPERS

Improvements In ADC Efficacy And Stability
Antibody–drug conjugates link antibodies to potent toxins, but increased hydrophobicity impairs stability, manufacturing, and PK, spurring interest in hydrophilic linker strategies.

Accelerated Development Of Solid Oral Dosage Formulation For IND Submission
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.
Optimizing Charge And N-glycan Profiles For CHO-Derived Fusion Proteins
Discover how structured design-of-experiment approaches can optimize charge variants and glycosylation to enhance biologics quality and therapeutic performance.
Process Development For Lyophilized Products
Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.
Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
Drug Development Plan Explained: DPP Templates And Examples
Only 6.7% of Phase 1 drugs reach approval. A well-structured Drug Development Plan (DDP) can meaningfully improve your odds — learn exactly how to build one.